Ireland
--:--IST
Recruiting Not applicable

Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC-01)

NCT04731610 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-12-28
Last updated
2026-04-20

Condition(s) studied

Thymoma Malignant Recurrent

Investigational drug(s) / intervention(s)

RadiotherapySurveillance after resection

Radiotherapy: postoperative radiotherapy after complete resection of thymoma

Surveillance after resection: Surveillance after tumour resection

Study summary

The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. 18 \< Age \< 75 years old 2. ECOG performance status ≤1 3. Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery should be realized ≤ 2 months after the last chemotherapy injection. 4. Histologically diagnosed thymoma at pathological examination of surgical specimen after pathological review; for note, centralized, real-time, systematic pathological review is standard through the RYTHMIC network in France 5. Complete resection at pathological examination of the surgical specimen after surgery conducted through standard, recommended approach ensuring accurate assessment of resection status 6. Stage IIb or III disease according to the Masaoka-Koga staging system; this corresponds to stage pT1a with capsule invasion, until stage pT3 N0 M0 in the 8th TNM staging system TNM UICC/AJCC 7. Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) or PET scan performed before surgery 8. Availability of a thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) showing absence of residual disease after surgical resection of the tumor 9. Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoretical value and DLCO ≥ 40% 10. Signature of informed consent form Exclusion Criteria: \- 1. Age \> 75 years old 2. Histology of thymic carcinoma 3. Delivery of post-operative chemotherapy, concurrent chemotherapy to radiotherapy 4. Presence of microscopic or macroscopic residual tumor after surgery or metastases (R1 or R2 resection) 5. Uncontrolled, clinically significant pleural or pericardial effusion 6. Patients with prior radiation therapy to the thorax. Patients treated with conformal radiotherapy for prior breast or head and neck neoplasms should be discussed with PI 7. Evidence of severe or uncontrolled systemic disease as judged by the investigator 8. Recent (\< 6 months) severe cardiac disease (uncontrolled arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease. Controlled and non clinically symptomatic arrhythmia is allowed. 9\. Current or past history of neoplasm diagnosed within the last 3 years, except: basal cell carcinoma of the skin, in situ carcinoma of the cervix, and bladder in situ. A patient diagnosed for another neoplasm 3 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected 10. Pregnancy or breast feeding or inadequate contraceptive measures for women of childbearing potential during PORT 11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls, 12. Patients deprived of freedom or under guardianship

Primary outcome measure(s)

  • Recurrence-Free survival (RFS) — 3 years
    to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

Trial sites (21)

FacilityCityRegionStatus
CHU Caen Caen France Recruiting
CLCC François BACLESSE Caen France Recruiting
CLCC Georges François Leclerc Dijon France Recruiting
Centre Oscar Lambret Lille France Recruiting
CHU Lyon Lyon France Recruiting
AP-HM Hôpital Nord Marseille France Recruiting
Institut du Cancer de Montpellier Montpellier France Not Yet Recruiting
Antoine LACASSAGNE Nice France Not Yet Recruiting
Institut Curie Paris France Recruiting
Hôpital Européen Georges Pompidou Paris France Not Yet Recruiting
Hôpital Bichat AP-HP Paris France Recruiting
CHU Haut Lévêque Pessac France Not Yet Recruiting
CHU Rennes Hôpital Sud Rennes France Recruiting
CHU Rouen Rouen France Withdrawn
CLCC Henri Becquerel Rouen France Not Yet Recruiting
Institut de Cancérologie de l'Ouest Saint-Herblain France Recruiting
CHU Strasbourg Strasbourg France Not Yet Recruiting
Institut Claudius Regaud Toulouse France Recruiting
CHRU Tours Tours France Recruiting
Institut de Cancérologie de Lorraine Nancy Vandœuvre-lès-Nancy France Recruiting
Gustave Roussy Villejuif France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04731610 on ClinicalTrials.gov ↗ ← All trials in France